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Proximal Reaming Guide 10mm 145 deg
EUDAMEDFDA UDIClass I (EU MDR)
Ref 14-142-000
Identity
- Trade Name
- Proximal Reaming Guide 10mm 145 deg EUDAMEDGLOBAL UNITE™ Short Stem Instrumentation FDA UDI
- Generic Name
- Orthopaedic reamer guide FDA UDI
- Device Name
- Proximal Reaming Guide 8mm 155 deg EUDAMEDSHORT PRX HUM REAMGUIDE 10 145 FDA UDI
- Model / Reference
- 14-142-000 EUDAMED230774100 FDA UDI
- Description
- SHORT PRX HUM REAMGUIDE 10 145 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847538018684 EUDAMEDFDA UDI
- Basic UDI-DI
- 08475380451093D EUDAMED
- Direct Marketing DI
- 00847538018684 EUDAMED
- 510(k) Number
- K211553 FDA UDI
- FDA Product Code
- PHX FDA UDIKWS FDA UDIHSD FDA UDI
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic reamer guide FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Proximal Reaming Guide 10mm 145 deg by Symmetry Medical Manufacturing, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08475380451093D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Symmetry Medical Manufacturing, Inc.
- EUDAMED SRN
- US-MF-000025394
- Authorised Representative
- SYMMETRY MEDICAL POLYVAC FR-AR-000003187
Sources (2)
- EUDAMED 48a2fd08-c5f8-4141-a179-08a3c819105e 61 fields · synced Jun 18, 2026
- FDA UDI 9e1a64ad-8f75-43c1-9735-3f7d66da4fef 34 fields · synced May 25, 2026